Mobile Health Application for Family Caregivers in Home Palliative Care

NCT07654998 | Not Yet Recruiting

• 1 other identifier: KSBU-MHEALTH-PC-2026-01
• Study Type: interventional
• Target: 120
• Locations: 1 country
• Sites: 1

Brief Summary

Family caregivers play a central role in providing daily care for patients receiving home palliative care. However, caregiving responsibilities may lead to increased burden, stress, and difficulties in symptom management and care coordination. Mobile health (mHealth) interventions may provide accessible education, symptom monitoring, and decision-support resources to improve caregiver outcomes and patient care. The aim of this randomized controlled trial is to evaluate the effectiveness of a mobile health application developed for family caregivers of patients receiving home palliative care. The primary outcome is caregiver competence. Secondary outcomes include caregiver burden, self-efficacy, patient symptom burden, emergency department visits, and hospitalizations. A total of 120 family caregivers will be randomly assigned to either the intervention group, which will use the mobile health application for 6 weeks in addition to usual care, or the control group, which will receive usual care alone. Outcomes will be assessed at baseline, post-intervention (Week 6), and follow-up (Week 18).

Conditions

Palliative Care; Cancer; Caregiver

Keywords

Mobile Health; Family Caregiver; Home Palliative Care; Caregiver Competence; Caregiver Burden

Outcome Measures

Primary Outcomes (1)

• Care Competency Scale for Family Caregivers in Home Palliative Care

  Caregiver competence will be assessed using the Care Competency Scale for Family Caregivers in Home Palliative Care. The scale consists of 29 items scored on a 1-5 Likert scale and evaluates caregiving knowledge, skills, preparedness, relational competence, emotional competence, and support-seeking competence. Total scores range from 29 to 145, with higher scores indicating greater caregiver competence.

  Baseline, post-intervention at 6 weeks, and follow-up at 18 weeks

Secondary Outcomes (5)

• Zarit Burden Interview

  Baseline, post-intervention at 6 weeks, and follow-up at 18 weeks

• General Self-Efficacy Scale

  Baseline, post-intervention at 6 weeks, and follow-up at 18 weeks

• Integrated Palliative Care Outcome Scale (IPOS) - Proxy Version

  Baseline, post-intervention at 6 weeks, and follow-up at 18 weeks

• Emergency Department Visits

  During the 18-week study period

• Hospitalizations

  During the 18-week study period

Other Outcomes (1)

• Mobile Application Usage and Adherence

  During the 6-week intervention period

Study Arms (2)

Mobile Health Application Plus Usual Care

EXPERIMENTAL

Participants will receive access to a mobile health application designed for family caregivers of patients receiving home palliative care in addition to routine home palliative care services. The intervention will be delivered for 6 weeks and includes educational content, symptom management support, caregiver self-care resources, medication management guidance, and healthcare utilization decision support.

Behavioral: Mobile Health Application

Usual Care Alone

NO INTERVENTION

Participants will receive routine home palliative care services provided by the home care unit. No mobile health application or additional structured intervention will be provided during the study period.

Interventions

Mobile Health Application BEHAVIORAL

Participants in the intervention group will receive access to a mobile health application developed for family caregivers of patients receiving home palliative care. The application includes educational modules on palliative care and symptom management, daily care skills, medication management, nutrition and hygiene, pressure injury prevention, caregiver self-care, stress management, problem-solving, and healthcare utilization decision support. Participants will use the application for 6 weeks in addition to routine home palliative care services.

Mobile Health Application Plus Usual Care

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Family caregiver of a patient receiving home palliative care services.
• Aged 18 years or older.
• Providing unpaid care to the patient for at least 3 months.
• Able to read and understand Turkish.
• Owns or has regular access to a smartphone compatible with the mobile application.
• Willing to participate and provide written informed consent.

You may not qualify if:

• Professional or paid caregivers.
• Participation in another structured caregiver support program during the study period.
• Cognitive, visual, or hearing impairments that would prevent effective use of the mobile application.
• Inability to complete study assessments.
• Withdrawal of consent at any stage of the study.

Sponsors & Collaborators

• Kutahya Health Sciences University: lead

Study Sites (1)

Simav Doc. Dr. Ismail Karakuyu State Hospital

Simav, Kütahya, 43500, Turkey (Türkiye)

Location

Related Publications (3)

• Kelley MM, Powell T, Camara D, Shah N, Norton JM, Deitelzweig C, Vaidy N, Hsiao CJ, Wang J, Bierman AS. Mobile Health Apps, Family Caregivers, and Care Planning: Scoping Review. J Med Internet Res. 2024 May 23;26:e46108. doi: 10.2196/46108.

  PMID: 38781588 BACKGROUND

• Yang X, Li X, Jiang S, Yu X. Effects of Telemedicine on Informal Caregivers of Patients in Palliative Care: Systematic Review and Meta-Analysis. JMIR Mhealth Uhealth. 2024 Apr 8;12:e54244. doi: 10.2196/54244.

  PMID: 38602303 BACKGROUND

• Yu Y, Xue H, Suo C, Wang H, Pang Y, Ji C, Hou W, Lu Y, Lu D, Sang L, Xu J, Li C, Jin L, Shi L, Zhang J, Liang J, Zhao W, Chen X. Palliative Care Educational App for Family Caregivers of Homebound Patients With Incurable Cancer : A Single-Center Randomized Trial. Ann Intern Med. 2025 Dec;178(12):1737-1751. doi: 10.7326/ANNALS-25-02346. Epub 2025 Sep 23.

  PMID: 40982976 BACKGROUND

MeSH Terms

Conditions

Neoplasms; Caregiver Burden

Condition Hierarchy (Ancestors)

Stress, Psychological; Behavioral Symptoms; Behavior

Central Study Contacts

Serkan Budak, PhD / RN

CONTACT

+905385430616; serkan.budak@ksbu.edu.tr

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Masking Details: Due to the nature of the mobile health intervention, participants and investigators cannot be blinded to group assignment.
• Purpose: SUPPORTIVE CARE
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Model Details: Participants will be randomly assigned in a 1:1 ratio to either an intervention group receiving access to the mobile health application in addition to usual home palliative care services or a control group receiving usual home palliative care services alone. Outcomes will be assessed at baseline, Week 6, and Week 18.

Study Record Dates

• First Submitted: June 12, 2026
• First Posted: June 17, 2026
• Study Start: June 10, 2026
• Primary Completion (Estimated): October 30, 2026
• Study Completion (Estimated): October 30, 2026
• Last Updated: June 17, 2026

Record last verified: 2026-06

Data Sharing

• IPD Sharing: Will not share

Locations

TU (1)